Diode Laser-Assisted Periodontal Therapy in Kidney Transplant Recipients

NCT07532694 | Recruiting

• 1 other identifier: MH103-KTR-PERIOLASER-RCT-2026
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized controlled trial evaluates the efficacy of diode laser-assisted non-surgical periodontal therapy in kidney transplant recipients with periodontitis. Eighty participants will be allocated to two parallel groups: scaling and root planing (SRP) with adjunctive diode laser therapy or SRP alone. Clinical periodontal parameters, blood biomarkers, radiographic findings, and subgingival microbiome profiles will be assessed at baseline and during follow-up. The study aims to determine whether adjunctive diode laser therapy provides superior clinical and biological improvement compared with SRP alone.

Conditions

Periodontitis; Kidney Transplant Recipients

Keywords

diode laser; scaling and root planing; periodontal therapy; kidney transplantation; 16S rRNA; microbiome; C-reactive protein

Outcome Measures

Primary Outcomes (2)

• Change in clinical attachment level (CAL)

  Mean change in CAL, measured in millimeters.

  Baseline, 1 month, 3 months, and 6 months

• Change in probing pocket depth (PPD)

  Mean change in CAL, measured in millimeters.

  Baseline, 1 month, 3 months, and 6 months

Secondary Outcomes (8)

• Change in bleeding on probing (BOP)

  Baseline, 1 month, 3 months, and 6 months

• Change in gingival index (GI)

  Baseline, 1 month, 3 months, and 6 months

• Change in plaque index (PlI)

  Baseline, 1 month, 3 months, and 6 months

• Change in OHI-S

  Baseline, 1 month, 3 months, and 6 months

• Change in platelet count

  Baseline, 1 month, 3 months, and 6 months

Study Arms (2)

SRP + diode laser

EXPERIMENTAL

Participants receive full-mouth scaling and root planing combined with adjunctive diode laser treatment according to the study protocol.

Procedure: Scaling and Root Planing; Device: Diode Laser

SRP alone

ACTIVE COMPARATOR

Participants receive full-mouth scaling and root planing alone according to the study protocol

Procedure: Scaling and Root Planing

Interventions

Scaling and Root Planing PROCEDURE

Conventional non-surgical periodontal therapy performed according to the study protocol in both groups.

SRP + diode laser; SRP alone

Diode Laser DEVICE

Adjunctive diode laser application to periodontal pockets after SRP in the experimental arm. Device specifications, wavelength, power settings, mode, fiber size, number of applications, and treatment sessions should match the approved protocol exactly.

SRP + diode laser

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Kidney transplant recipients aged 18 years or older.
• Diagnosis of periodontitis according to the study case definition.
• Medically stable and able to undergo non-surgical periodontal treatment.
• Willing and able to provide written informed consent and attend follow-up visits.

You may not qualify if:

• Acute oral infection requiring urgent treatment.
• Pregnancy or lactation, if excluded by the approved protocol.
• Serious systemic condition or clinical instability judged by investigators to preclude study participation.
• Inability to comply with study procedures or follow-up schedule.

Sponsors & Collaborators

• Military Hospital 103: lead

Study Sites (2)

103 Military Hospital

Hanoi, Hadong, 100000, Vietnam

RECRUITING

Vietnam Military Medical University

Hanoi, QUẬN HÀ ĐÔNG, 100000, Vietnam

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing; Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Thang V Dinh, Principal Investigator

CONTACT

+84971349066; bsdinhthang277@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single or double masking only if the protocol truly supports it; otherwise choose None (Open Label). Recommended: Outcomes Assessor masked, if examiner blinding is feasible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 16, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): June 9, 2026
• Study Completion (Estimated): June 9, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

VN (2)